Clinical trial · Observational
A Study of Prevalence of HER3 Expression in Non-Small Cell Lung Cancer
HER3 Prevalence in Archival Tissue and Associated Real World (RW) Data From Non-Small Cell Lung Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is currently a lack of published HER3 expression prevalence data among non-small cell lung cancer (NSCLC) patients. The estimation of HER3 expression prevalence in this population using archival tissue samples and the assessment of associated patient characteristics in real world (RW) data will ultimately inform clinical strategy and increase awareness among health care providers (HCPs) and the greater medical community to improve patient care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Archival tissue specimen and immunohistochemistry staining | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Cohort 1: NSCLC
- description
- Participants with NSCLC will be included in this cohort if they do not meet requirements for inclusion in Cohorts 2-4.
- interventionNames
- Other: Archival tissue specimen and immunohistochemistry staining
- label
- Cohort 2: EGFR-mutated (EGFRm) NSCLC Previously Treated With a 3rd Generation EGFR TKI
- description
- Participants with EGFR-mutated (EGFRm) NSCLC previously treated with a 3rd generation tyrosine kinase inhibitor (TKI) with matched samples.
- interventionNames
- Other: Archival tissue specimen and immunohistochemistry staining
- label
- Cohort 3: ALK+ NSCLC
- description
- Participants with ALK+ NSCLC with matched samples.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years in US * Histologically or cytologically documented advanced or metastatic NSCLC * At least one sample available and evaluable for HER3 expression Additional population-specific inclusion criteria: For Cohort 1: * Tissue sample collected on or after January 1, 2013 For Cohort 2: * EGFRm NSCLC previously treated with a 3rd generation EGFR TKI * 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a 3rd generation TKI (defined as Osimertinib, Aumolertinib \[formerly Almonertinib\]) For Cohort 3: * ALK+ NSCLC * 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment, where the treatment is a TKI For Cohort 4: * NSCLC harboring a KRAS p.G12C mutation or EGFR exon 20 insertion * 2 samples are available and evaluable for HER3 expression at 2 timepoints: one pre-treatment and one post-treatment Exclusion Criteria: * Prior treatment with an anti-HER3 antibody or topoisomerase I inhibitor (single-agent or combination) * Prior treatment with an antibody drug conjugate (ADC) that contains a topoisomerase I inhibitor * Previous histologic or cytologic evidence of small cell or combined small cell/non-small cell disease
References
Publications (0)
Data not yet available